BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FTD SARS-COV-2

    MDR report key: 10372355 · Received August 6, 2020

    Report

    Report Number
    1219913-2020-00194
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 6, 2020
    Manufacturer
    FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO.
    Product Code
    QJR
    UDI-DI
    05400829005883
    PMA / PMN Number
    EUA200571
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEGATIVE CONTROLS AND KNOWN NEGATIVE SAMPLES CONTINUOUSLY RESULT AS EXPECTED. THE CUSTOMER USES A WORKLFLOW (HIMEDIA SWABS WITH QUANTSTUDIO 5DX (THERMO FISHER SCIENTIFIC) IN COMBINATION WITH QIASYMPHONY® SP INSTRUMENT AND MANUAL EXTRACTION KIT FROM QIAGEN) THAT WAS NOT VALIDATED BY FTD - A SIEMENS HEALTHINEERS COMPANY WITH THE SARS-COV-2 PCR TEST. THE FTD SARS-COV-2 LIMIT OF DETECTION (LOD) AS DESCRIBED IN THE INSTRUCTIONS FOR USE (IFU), IS CT 37.4-38.0. THE IFU STATES IN THE LIMITATIONS SECTION: "THE PERFORMANCE OF THE KIT HAS BEEN VERIFIED AND VALIDATED USING THE PROCEDURES PROVIDED IN THE INSTRUCTIONS FOR USE ONLY. MODIFICATIONS TO THESE PROCEDURES MAY ALTER THE PERFORMANCE OF THE TEST." "OTHER PARAMETERS CAN LEAD TO FALSE POSITIVE, NEGATIVE OR INVALID RESULTS RELATED TO PATIENT CONDITIONS (USE OF ANTIVIRAL THERAPY, PATIENT AGE, PATIENT HISTORY OF RESPIRATORY INFECTIONS, PRESENCE OF SYMPTOMS AND THE STAGE OF INFECTION)." "LOW LEVELS OF VIRUSES CAN BE DETECTED BELOW THE LIMIT OF DETECTION, BUT RESULTS MAY NOT BE REPRODUCIBLE." LIMITED INFORMATION HAS BEEN PROVIDED DESPITE FTD - A SIEMENS HEALTHINEERS COMPANY'S ATTEMPTS TO COLLECT. THE CUSTOMER HAS DECIDED NOT TO CONTINUE USING THE FTD SARS-COV-2 PCR TEST, THEREFORE IT IS NOT EXPECTED THAT FURTHER INFORMATION WILL BE PROVIDED. A FALSE POSITIVE RESULT WOULD HAVE NEGLIGIBLE CLINICAL IMPACT AS MANAGEMENT AND TREATMENT DECISIONS ARE BASED ON SEVERITY OF CLINICAL PRESENTATION AND MANAGEMENT PRIMARILY CONSISTS OF SUPPORTIVE CARE. ALTHOUGH THERE IS NO POTENTIAL FOR SERIOUS INJURY IN THIS CASE, AN MDR WILL BE REPORTED TO THE FDA AS A REQUIREMENT OF THE EMERGENCY USE AUTHORIZATION (EUA). BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION OF A PRODUCT PROBLEM. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED 10 FALSE POSITIVE RESULTS USING THE FTD SARS-COV-2 PCR TEST WITH LOW CT AROUND 34 THAT WERE NEGATIVE USING THERMO FISHER TAQPATH AND ANOTHER WIDELY USED KIT IN (B)(6), TRUPCR. REPEAT TESTING OF THE SAME ELUATES WITH THE FTD SARS-COV-2 TEST REMAINED POSITIVE. THESE RESULTS WERE NOT REPORTED TO PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE SARS-COV-2 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840671 FTD SARS-COV-2 REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR FAST TRACK DIAGNOSTICS-A SIEMENS HEALTHINEERS CO. N/A SC20-32-03 05400829005883

    Patients

    Seq Age Sex Outcome Treatment
    1